ISO/TS TECHNICAL SPECIFICATION 17518 First edition 2015-04-15 Medical laboratories Reagents for staining biological material - Guidance for users Laboratoires medicaux - Réactifs pour coloration du matériel biologique Directives pour les utilisateurs Reference number ISO/TS 17518:2015(E) ISO @IS02015 IS0/TS 17518:2015(E) COPYRIGHTPROTECTEDDOCUMENT @ISO2015 All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized otherwise in any form writtenpermission.Permission canberequestedfromeitherIsOattheaddressbelow orIso'smemberbodyinthecountryof the requester. ISO copyright office Case postale 56 · CH-1211 Geneva 20 Tel. + 41 22 749 01 11 Fax + 41 22 749 09 47 E-mail [email protected] Web www.iso.org Published in Switzerland i @ IS0 2015 - All rights reserved IS0/TS 17518:2015(E) Contents Page Foreword ..iv Introduction. .. 1 Scope. ..1 2 Normative references 3 Terms and definitions ..1 4 Acquiring reagents for in vitro diagnostic staining in biology .8 4.1 General principles .8 4.2 Manufacturer name. .8 4.3 Identification of kit components ..8 5 Information associated with the in vitro diagnostic reagent .8 5.1 Intended use .8 5.2 Instructions for use . .9 5.3 Identification of the reagent for staining of biological samples .9 5.3.1 Reagent name 9 5.3.2 Description of IVD reagent for staining of biological samples .10 5.3.3 Batch code .10 5.3.4 Contents .10 5.4 Storage and handling conditions 10 5.5 Expiry date.. .10 5.6 Warnings and precautions .11 5.7 Additional information for specific kinds of reagents .11 5.7.1 Fluorochromes. 11 5.7.2 Metal salts 11 5.7.3 Additional required equipment 11 5.7.4 Reagent preparation .11 5.7.5 Control procedure.. .11 5.7.6 Interpretation .12 5.7.7 Limitations of the examination procedure .12 5.7.8 Literaturereferences 12 6 Validation and verification of biological stains .12 6.1 General Information. 12 6.2 Validation for the intended use 13 6.3 Verification of the specifications .13 6.4 Certification of biological dyes. .13 6.5 Acquisition of biological stains and dyes. .13 Annex A (informative) Checklist for establishing or verifying specifications for biological stains and dyes.. 14 Bibliography ..15 @ IS0 2015 - All rights reserved ii